Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Documentation
Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the issue is a lack of documentation to verify sterility audits rather than a confirmed contamination or reported injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Superstat Corporation is recalling 26,422 units of Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. The affected product is identified by Lot# SSN02D. This medical device is indicated for use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses.
The recall was initiated because Superstat Corporation confirmed that no documentation is available to verify that quarterly dose sterility audits were performed for the product. The agency classification for this recall is Class II.
The affected units were distributed worldwide, including the United States (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore. Healthcare providers and facilities should stop using the affected product and contact Superstat Corporation for further instructions.
The recalled product
- Product
- Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capilla
- Manufacturer
- Superstat Corp
- Affected units
- 26,422
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot# SSN02D.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Superstat Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same manufacturer · Superstat Corp
See all →- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records
FDA (Devices) · 2012-11-28
- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled for Sterility Audit Documentation Gaps
FDA (Devices) · 2012-11-28
- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
FDA (Devices) · 2012-11-28
- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
FDA (Devices) · 2012-11-28
- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
FDA (Devices) · 2012-11-28
Same hazard · sterility verification
See all →- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation
FDA (Devices) · 2012-11-28
- ModerateSuperstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Documentation
FDA (Devices) · 2012-11-28